Norris 1989.
Study characteristics | ||
Methods | Study design: split‐body, randomised, double‐blinded, double‐paired, controlled trial to evaluate increasing concentrations of polidocanol Method of randomisation: not mentioned Blinding: patient ‐ yes, treating doctor ‐ yes Power calculation: not stated Number of patients randomised: 20 (4 quadrants of each patients's lower limbs) Number of patients analysed: 16 Number of exclusions post randomisation: 0 Number of withdrawals and reasons: 4 Source of funding: not stated |
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Participants | Setting: outpatient centre Country: USA Total number: 20 Age: range from 30 to 57 years old Sex: female Inclusion criteria: "bilaterally symmetric telangiectasias of the legs and thighs" Exclusion criteria: history of phlebitis, current hormone, disulfiram or anticoagulant use |
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Interventions | Each patient's legs were divided into 4 quadrants: 1) treated with polidocanol (POL) 0.25% 2) treated with POL 0.5% 3) treated with POL 0.75% 4) treated with POL 1% All patients wore anti‐embolism elastic stockings with gradient pressure for at least 48 hours after treatment, and for as much as possible 2 weeks thereafter Duration: patients were treated every 4 weeks until vessel disappearance or up to a maximum of 6 visits (24 weeks) |
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Outcomes | 1) Efficacy: treating physician (2 study authors) rating of colour photos taken at baseline and prior to each treatment, rated as poor‐to‐moderate, good, excellent 2) Adverse events: a) itching: rated by patient as none or present b) hyperpigmentation: rated by investigators as none or present c) neovascularisation: rated by investigators as none or present 3) patient satisfaction: dissatisfied, neither satisfied or dissatisfied, satisfied, very satisfied 4) number of treatments to clear each quadrant from 1 to >6 |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned. Unsuccessful in attempt to contact authors. |
Allocation concealment (selection bias) | Low risk | "Injections were labelled and coded as an unknown and randomly assigned." |
Blinding (performance bias and detection bias) All outcomes | Low risk | States double‐blinded but no further details given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Explanations were provided for the 4 patients who dropped out, and the reasons provided indicate this was unlikely to impact effect size. |
Selective reporting (reporting bias) | Low risk | All specified outcomes were reported. |
Other bias | High risk | The study design divides each person's legs into four quadrants to receive separate simultaneous treatments and analysis, and thereby risks bias by carry‐across effect. |